Promotion of Breastfeeding and Evaluation Study: a community-based maternal-focused approach to promote exclusive breastfeeding in rural Pakistan

ISRCTN	ISRCTN45752079
DOI	https://doi.org/10.1186/ISRCTN45752079
Secondary identifying numbers	N/A

Submission date: 22/04/2009
Registration date: 29/06/2009
Last edited: 29/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Atif Rahman
Scientific

Child & Adolescent Psychiatry
School of Population, Community & Behavioural Sciences
Royal Liverpool Children's Hospital
Eaton Road
Liverpool
L12 2AP
United Kingdom

Phone	+44 (0)151 252 5509
Email	atif.rahman@liverpool.ac.uk

Study information

Study design	Cluster randomised single-blind parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Integration and evaluation of a community-based maternal-focused approach to promote exclusive breastfeeding in rural Pakistan: a cluster randomised controlled trial
Study acronym	PROBE Study
Study objectives	The aim of this project is to provide the National Program for Family Planning and Primary Health Care of Pakistan and their Lady Health Workers (community health workers) with a well-researched, evidence-based intervention to promote exclusive breastfeeding, which has the potential for up-scaling. The objective of the project is to integrate a community-based exclusive breastfeeding promotion intervention into the routine work of Lady Health Workers, train them in using this approach, and to evaluate its effect on rates of exclusive breastfeeding. Hypotheses: Compared to mothers receiving standard breastfeeding advice by Lady Health Workers, mothers who receive the experimental intervention (also by Lady Health Workers) will: 1. Have a higher rate of exclusive breastfeeding (defined as giving maternal milk at the only infant food source in the previous week, with no other liquids or food given) at 6 months post-natally 2. Have a longer duration of exclusive breastfeeding 3. Have reduced levels of psychosocial distress
Ethics approval(s)	Human Development Research Foundation, registered with the Office of Human Research Protections (OHRP), gave approval on the 10th December 2008 (ref: HDRF/IRB/002)
Health condition(s) or problem(s) studied	Breastfeeding
Intervention	The proposed study is a cluster randomised controlled trial with two parallel arms. The intervention arm will receive seven sessions of this maternal focused approach to promote breastfeeding through Lady Health Workers. The control arm will receive a similar number of visits of routine counselling for breastfeeding through different Lady Health Workers.
Intervention type	Other
Primary outcome measure	All assessments will be carried out using instruments that have been translated, field-tested and validated in the local population through our previous work. Assessments will be carried out at baseline (third trimester), and prospectively for 6 months after birth. Baseline measures: 1. Socioeconomic status (household income and assets) 2. Maternal age 3. Education 4. Body mass index 5. Scores of psychosocial distress on the Self-Reporting Questionnaire (SRQ) 6. Number of children 7. Family structure 8. Levels of post-traumatic stress and depressive reactions to the 2005 earthquake in the study area, assessed using the Earthquake Exposure Scale Main outcome: The duration of exclusive breastfeeding (EBF) and its rate at 6 months, measured prospectively using the following method: each mother enrolled into the study will be visited fortnightly by an independent team, blind to the allocation status of the mother, to record the breastfeeding status and practice in the last 24 hours. For this study, EBF was defined as: only breastfeeding being practiced with no other semi-solid or liquid foods (other than medication and/or oral rehydration solutions).
Secondary outcome measures	1. Psychological distress, measured at baseline, 3 and 6 months using the Self-Reporting Questionnaire (SRQ-20). This psychiatric screening instrument, which was developed specifically for use in primary care by health workers in developing countries, has 20 items with a 'yes' or 'no' response to questions about psychological and somatic symptoms in the past 30 days. 2. Rates and duration of predominant and partial breastfeeding, assessed at 6 months of infant's age prospectively using the above mentioned method 3. Process outcomes: studied qualitatively using key-informant interview and focus groups. At the 'system' level, the opinion of key personnel from the programme and primary health care (including LHWs), will be obtained on all aspects of training, delivery, usefulness and potential costs of the intervention (in terms of extra time and material needed to deliver the intervention). At the family level, we will obtain feedback from mothers and other significant family members about the intervention.
Overall study start date	01/05/2009
Completion date	01/06/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	440 third trimester pregnant women
Total final enrolment	452
Key inclusion criteria	1. Married, consenting women 2. Aged 17 - 40 years 3. Pregnant; in their 3rd trimester of pegnancy
Key exclusion criteria	1. A diagnosed medical or mental illness 2. Currently under treatment, e.g., tuberculosis, hepatitis B or C or a mental health illness
Date of first enrolment	01/05/2009
Date of final enrolment	01/06/2010

Locations

Countries of recruitment

England
Pakistan
United Kingdom

Study participating centre

Child & Adolescent Psychiatry

Liverpool
L12 2AP
United Kingdom

Sponsor information

University of Liverpool (UK)
University/education

c/o Prof. Atif Rahman
Child and Adolescent Psychiatry
School of Population, Community & Behavioural Sciences
Royal Liverpool Children's Hospital
Mulbery House
Eaton Road
Liverpool
L 12 2AP
United Kingdom

Phone	+44 (0)151 252 5509
Email	atif.rahman@liverpool.ac.uk
Website	http://www.liv.ac.uk/
"ROR"	https://ror.org/04xs57h96

Funders

Funder type

Research organisation

United States Agency for International Development (USAID) (USA) - International Rescue Committee, Inc (IRC-PRIDE)

No information available

University of Liverpool (UK)
Government organisation / Universities (academic only)

Alternative name(s): The University of Liverpool, 利物浦大学, Universidad de Liverpool, UoL
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2015	29/12/2020	Yes	No

Editorial Notes

29/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.